Innoveix Lyophilized HCG 5500 Units Recall: Lack of Sterility Risk
Innoveix Pharmaceuticals recalls compounded Lyophilized Human Chorionic Gonadotropin 5,500 USP Units for injection due to lack of sterility assurance. This affects specific lots manufactured in Addison, TX. Contact for details.
Recall notice
Lack of Sterility Assurance.
Contact the company
What happened, in plain English
Innoveix Pharmaceuticals compounded Lyophilized Human Chorionic Gonadotropin 5,500 USP Units for injection is being recalled because it lacks sterility assurance. This means the product could be contaminated, posing a risk of infection if used. Read more at govinfonow.com/recall/37859-innoveix-lyophilized-hcg-5500-units-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37859-innoveix-lyophilized-hcg-5500-units-recall-lack-of-sterility-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0160-2020
Cite this page
“Innoveix Lyophilized HCG 5500 Units Recall: Lack of Sterility Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37859-innoveix-lyophilized-hcg-5500-units-recall-lack-of-sterility-risk. Based on FDA recall #D-0160-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0160-2020%22&limit=1).
Why it’s dangerous
The product lacks sterility assurance, meaning it may contain harmful bacteria or other contaminants. If injected, this could cause serious infections or other health issues.
Who’s affected
Patients prescribed this compounded hormone for fertility treatments in the U.S. are affected. Those using the product without a prescription or for non-medical purposes are not covered.
How to tell if you have this one
Check for the lot number INX 50 with expiration date 5/1/20 on the packaging. This product was compounded by Innoveix in Addison, TX.
- Brand
Innoveix- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0157-2020 | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20 | 3905 vials |
| D-0158-2020 | Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20 | 413 vials |
| D-0159-2020 | Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lots: SER 925 Exp. 11/4/19; SER 930 Exp. 11/18/19; SER 935 Exp. 2/21/20; SER 400 Exp. 4/1/20; SER 405 Exp. 5/11/20; SER 410 Exp. 7/15/20 | 1747 vials |
| D-0160-2020 | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lots: INX 50 Exp. 5/1/20 | 290 vials |
What to do — step by step
Stop Using It Now
Discard the product immediately if you have it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0160-2020 (October 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0160-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.